Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer

Trial Information

Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer

Group I : The SLN procedure will be initiated 18 hours before surgery using a preoperative
injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio
International, France) at the four cardinal points in the subareolar area.
Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery,
the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During
surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In
order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be
measured immediately after their resection by a gamma ray counter and they will then be
submitted to pathological analysis with frozen section.

Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative
injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio
International, France) at the four cardinal points in the subareolar area.
Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery,
the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During
surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In
order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be
measured immediately after their resection by a gamma ray counter and they will then be
submitted to pathological analysis with frozen section. After SLN removal and during the
pathological analysis, the axillary area will once again be checked using the CarolIReS
camera (followed by a further surgical excision in the case of remaining SLNs).

When the pathological analysis will diagnose a metastatic SLN, complete axillary lymph node
dissection (ALND) will immediately be performed. In the case of negative SLN, serial
sections and detection of cytokeratine (AE1/AE3; Dako, Zymed, CA, USA) will be performed
during standard pathological analysis. Macrometastases will be defined as clusters of cancer
cells ≥2 mm, micrometastases as clusters of cancer cells ≥0.2 mm and <2 mm, and isolated
cancer cells as clusters of cancer cells <0.2 mm. ALND will be performed in cases of macro-
or micrometastases.

Inclusion Criteria:

- Patient major at the time of breast surgery.

- Patient affiliated with a social security.

- Consent dated and signed by the investigator and the subject.

- Subject having been informed of the sentinel lymph node procedure during the visit
prior to breast surgery.

Name

Location

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